Duns Number:658023275
Device Description: The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the h The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages.
Catalog Number
-
Brand Name
TekCare Touch Free Infrared Thermometer
Version/Model Number
NT11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
44b5fe1e-98d9-4b8a-8b2c-021a1851b681
Public Version Date
January 31, 2019
Public Version Number
1
DI Record Publish Date
December 31, 2018
Package DI Number
04710953421307
Quantity per Package
40
Contains DI Package
04710953421291
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |